Biomed Inc Research Articles

Outcome of Regenerative Endodontic Procedures in Nonvital Immature Permanent Teeth Using 2 Intracanal Medications: A Prospective Randomized Clinical Study

IntroductionThis randomized clinical trial aimed to assess and compare the long-term clinical and radiographic outcomes of regenerative endodontic procedures (REPs) in treating nonvital immature permanent teeth using 2 intracanal medicaments. MethodsForty-five patients yielding a total of 50 anterior and posterior nonvital immature teeth were randomly divided into 2 groups. REPs using either nonsetting calcium hydroxide (Ca[OH]2) (n = 25) or modified triple antibiotic paste (TAP) (n = 25) as intracanal medicaments were performed. NeoMTA Plus (Avalon Biomed Inc) was applied for coronal sealing. Cases were followed up clinically and radiographically for 36 months. The survival rate, success rate, and clinical outcome measures were analyzed. Preoperative and recall radiographs were evaluated for dimensional changes in root length, dentin thickness, apical diameter, and periapical radiolucency. ResultsAt the 36-month follow-up, the success and survival rates were 81.6% and 100%, respectively, in which 79.4% of cases showed complete resolution of periapical radiolucency with no significant difference between the nonsetting Ca(OH)2 and modified TAP groups (P > .050). The cumulative changes in root length, root dentin thickness, and apical diameter throughout the study period were observed in 47.9%, 77.1%, and 89.6% of cases, respectively, with no significant differences between groups (P ≥ .39). Intracanal calcifications were detected in 60% of cases with no significant difference between groups (P = .77). ConclusionsREPs, using either nonsetting Ca(OH)2 or modified TAP as the intracanal medicament, exhibited high success and survival rates over a follow-up period of 36 months with equally favorable clinical and radiographic outcome data.

ROOT CANAL FILLING WITH NEOMTA PLUS IN SECOND PRIMARY MOLAR TEETH WITH MISSING SUCCESSOR: TWENTY-FOUR MONTHS OF FOLLOW-UP

Hypodontia of the mandibular second premolar teeth is one of the most frequent anomalies of tooth development, which reveals a unique hardship for clinicians. Retaining the primary second molars helps to maintain arch integrity until facial growth is complete. This case series investigates the potential improvement and longevity of retained primary mandibular second molars obturation of the root canal system using a mineral trioxide aggregate when successors are missing. Neo MTA Plus (Avalon Biomed Inc, Bradenton, FL) recently introduced calcium silicate-based cement that may have some potential as a root canal obturating material. Nevertheless, no study using Neo MTA Plus as a root canal filling material was found in the literature. Five female patients with a decayed, necrotic second primary molar tooth without a successor were selected and performed a root canal treatment with Neo MTA Plus. Patients were scheduled for clinical and radiographic evaluation at 6, 12, 18, and 24 months. They were followed up for twenty-four months. According to the present study, it can be concluded that NeoMTA Plus maybe a proper material for use in the root canal treatment of primary molars with a missing successor.

4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate–based Material

IntroductionThis study aimed to assess the pulpal and restorative outcome of full pulpotomy in symptomatic mature permanent teeth with carious pulp exposure over 4 years. MethodsUnder local anesthesia, full pulpotomy was performed using the aseptic technique and a stainproof calcium silicate–based material (NeoMTA Plus; Avalon Biomed Inc, Bradenton, FL). The pain level was scored preoperatively and at 1 week posttreatment. Clinical and radiographic evaluation was performed at 6 months, 1, 2, and 4 years. Kaplan-Meier survival analysis and Cox proportional hazards regression were used to analyze the data. Failed cases were classified as endodontic or restorative failure. ResultsFull pulpotomy was completed in 109 teeth in 90 patients with an age range of 14–60 years (mean = 25 years). The study sample available for follow-up was 100 teeth in 86 patients with a recall rate above 90%. Preoperative pulp diagnosis was reversible pulpitis in 39 teeth and irreversible pulpitis in 61 teeth. The cumulative survival rates of pulpotomy were generally high (ie, 98%, 97.4%, 93%, and 83.8% at 6 months and 1, 2, and 4 years, respectively). The overall mean survival time of pulpotomy was 3.89 years (95% confidence interval, 3.84–3.95). The mean survival time was significantly higher for patients aged ≤25 years. However, in the multivariate analysis, the only significant predictor of pulpotomy failure was severe preoperative pain. Over the 4 years, 23 cases failed; only 10 of 23 failures were classified as endodontic failure, and the success of pulpotomy can be assumed to be 90%. ConclusionsFull pulpotomy in cariously exposed pulp of mature permanent teeth sustained a high success rate over 4 years. The coronal seal is crucial for long-term survival.

The Osteogenic Assessment of Mineral Trioxide Aggregate–based Endodontic Sealers in an Organotypic Ex Vivo Bone Development Model

IntroductionMineral trioxide aggregate (MTA)-based sealers are endodontic materials with widespread success in distinct clinical applications, potentially embracing direct contact with the bone tissue. Bone response to these materials has been traditionally addressed in vitro. Nonetheless, translational data are limited by the absence of native cell-to-cell and cell-to-matrix interactions that hinder the representativeness of the analysis. Ex vivo organotypic systems, relying on the culture of explanted biological tissues, preserve the cell/tissue composition, reproducing the spatial and organizational in situ complexity. This study was grounded on an innovative research approach, relying on the assessment of an ex vivo organotypic bone tissue culture system to address the osteogenic response to 3 distinct MTA-based sealers. MethodsEmbryonic chick femurs were isolated and grown ex vivo for 11 days in the presence of MTA Plus (Avalon Biomed Inc, Bradenton, FL), ProRoot MTA (Dentsply Tulsa Dental, Hohnson City, Germany), Biodentine (Septodont, Saint Maurdes Fosses, France), or AH Plus (Dentsply Sirona, Konstanz, Germany); the latter was used as a control material. Femurs were characterized by histologic, histochemical, and histomorphometric analysis. Gene expression assessment of relevant osteogenic markers was conducted by quantitative polymerase chain reaction. ResultsAll MTA-based sealers presented an enhanced osteogenic performance compared with AH Plus. Histochemical and histomorphometric analyses support the increased activation of the osteogenic program by MTA-based sealers, with enhanced collagenous matrix deposition and tissue mineralization. Gene expression analysis supported the enhanced activation of the osteogenic program. Comparatively, ProRoot MTA induced the highest osteogenic functionality on the characterized femurs. ConclusionsMTA-based sealers enhanced the osteogenic activity within the assayed organotypic bone model, which was found to be a sensitive system for the assessment of osteogenic modulation mediated by endodontic sealers.

The Bond Strength of Universal Adhesives with Different Acidities to Calcium Silicate-Based Materials

Objective: To compare the micro-shear bond strengths of 3 different universal adhesives to 2 different calcium silicate-based materials. Methods: A hole was prepared in the center of the top surfaces of 60 cylindrical acrylic blocks, and the blocks were randomly divided into 2 groups (n=30) according to biomaterial filling; NeoMTA Plus (Avalon Biomed Inc. Bradenton, FL, USA) and ProRoot MTA (Dentsply Tulsa, Tulsa, OK, USA). Biomaterials were prepared according to the manufacturers’ instructions. The sample surfaces were flattened after the initial setting, and the samples were incubated for 24h at 37°C. After placing the biomaterials in the prepared holes, the specimens were randomly divided into 3 subgroups (n=10) according to adhesive; G-Premio Bond (GC Corp., Tokyo, Japan), All-Bond Universal (Bisco, Inc., Schaumburg, IL, USA) and Single Bond Universal (3M ESPE, St Paul, MN, USA). Adhesives were applied to the specimens and polymerized. A micro-hybrid composite resin (Filtek Z250, 3M ESPE, MN, USA) was then placed on the specimen surfaces and polymerized. Micro-shear bond strengths were tested using a universal testing device (LRX, Lloyd Instruments, Farnham, UK). A Shapiro-Wilk test confirmed normal distribution, and 2-way ANOVA was used for statistical analysis. Result: No significant differences were found in the shear bond strengths of any of the tested adhesives to either of the calcium silicate-based materials (p>0.05). Conclusion: The results indicate that the acidity of a universal adhesive does not affect the bond strength of composite resin to calcium silicate-based materials.

A Comparative Study of Surface Hardness between Two Bioceramic Materials in an Experimental Apexification Model under Wet and Dry Conditions

Background:The placement of a wet cotton pellet against Mineral Trioxide Aggregate (MTA) is often recommended to ensure the completion of its setting reaction.Objective:This study aimed to evaluate the setting behaviour of MTA Angelus and NeoMTA by comparing their hardness after placing them in dry and moist conditions.Methodology:A simulated open apex was created on 40 polyvinyl tubes. The apical 4 mm of the tubes was filled with the two materials, NeoMTA Plus (Avalon Biomed Inc. Bradenton, FL, USA) and MTA Angelus (Angelus, Londrina, PR, Brazil) (n=20 per group). Both groups were subdivided into two subgroups based on the dry and wet conditions (n=10 per group). A wet cotton pellet was placed above the two materials in the wet group, and the coronal segment was sealed using Type II Glass ionomer cement (GC corporation Tokyo, Japan). Gutta-percha was placed against the test materials in the dry group with the coronal segment sealed with amalgam. Samples were placed in an oasis soaked in phosphate-buffered saline for seven days in 100% humidity and at 37°C. Microhardness was measured independently at 4 and 2 mm from the apex. Hardness was compared between materials and conditions, applying analysis of variance (a = .05).Results:The presence of dry or wet conditions had no significant effect on material hardness. MTA Angelus showed significantly higher hardness values compared with NeoMTA Plus.Conclusion:The moisture of the periapical environment can compensate for the absence of a wet cotton pellet and is adequate for the setting of the materials.

1629-P: Association of Patient-Reported Outcomes (PROs) Scores with Glycemic Target Achievement in Type 1 Diabetes (T1D) in the SAGE Study

T1D is a chronic disease affecting both physical and psychosocial health. SAGE was a multinational, cross-sectional observational study using data from medical records and interviews of people (N=3858) aged ≥26 years with T1D for ≥1 year. The association between the achievement of general (HbA1c <7 %) or individualized HbA1c targets and PRO scores was analyzed by multivariate logistic regression, adjusted for region and age group. The following PROs are reported: Hypoglycemia Fear Survey (HFS-II) worry subscore, Problem Areas in Diabetes (PAID), Insulin Treatment Satisfaction Questionnaire (ITSQ), Audit of Diabetes-Dependent Quality of Life (ADDQoL). Overall, 24.3% of people achieved the general HbA1c target; 20.9% achieved individualized targets (most common target, HbA1c 7 % to <7.5 %). Lower emotional distress (PAID score) and higher treatment satisfaction (all ITSQ scores except Lifestyle domain) were associated with achievement of general and individualized HbA1c targets (Table). Lower HFS-II worry score and higher ADDQoL total scores were associated with achievement of HbA1c general target, but neither was associated with achieving individualized HbA1c targets. In people with T1D, lower diabetes-related emotional distress and higher treatment satisfaction appear to be associated with achievement of both general and individualized HbA1c targets. Disclosure E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. F. Ampudia Blasco: None. L. Berard: Consultant; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Becton, Dickinson and Company, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Montméd, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd. S. Brette: Other Relationship; Self; Sanofi. L.P. Calliari: Board Member; Self; Abbott, Medtronic, Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Lilly Diabetes. E. Fitts: Other Relationship; Self; N/A. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck & Co., Inc. J.J. Gagliardino: None. F. Lauand: Employee; Self; Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. A. Roborel de Climens: Employee; Self; Sanofi. J. Seufert: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Sanofi.

1129-P: Effect of Sotagliflozin Added to Insulin Therapy on Beta-Hydroxybutyrate in Patients with Type 1 Diabetes

Objective: To evaluate the effect of sotagliflozin (SOTA), a dual SGLT 1 and 2 inhibitor, on beta-hydroxybutyrate (BHB) over 52 weeks in adults with type 1 diabetes (T1D) on insulin therapy. Methods: Analyses were performed on pooled data from two, 52-week, placebo-controlled studies in 1575 adult patients with T1D on optimized insulin therapy, who were randomly assigned 1:1:1 to placebo (PBO), SOTA 200 mg, and SOTA 400 mg. Descriptive statistics were performed on serum BHB using results from scheduled visits at baseline and Weeks 4, 12, 24, and 52. A 2-sample Wilcoxon rank sum test was performed to test the distribution of change in BHB from baseline between SOTA and placebo. The proportion of patients experiencing ≥1 measurement meeting predefined limits of DKA risk based on BHB levels (≥0.6 mmol/L “ketonemia” and ≥1.5 mmol/L “impending DKA”) was assessed. Results: Median baseline BHB was 0.13 (IQR 0.10, 0.20), 0.13 (IQR 0.10, 0.22), and 0.14 mmol/L (IQR 0.10, 0.23) in the PBO, SOTA 200-mg, and SOTA 400-mg groups, respectively. While the median change in BHB was 0 mmol/L with PBO, median BHB increased from baseline by 0.03 to 0.05 mmol/L with SOTA, and generally remained stable over 52 weeks (p<0.001 vs. PBO at each time point). Per the predefined limits of DKA risk based on BHB levels, a BHB level ≥0.6 mmol/L was experienced by 19.8, 46.9, and 45.5% and a BHB level ≥1.5 mmol/L in 2.1, 6.3, and 8.2% of patients on PBO, SOTA 200 mg, and SOTA 400 mg, respectively. Approximately 2/3 of the BHB ≥0.6 mmol/L events were observed by Week 16 and ∼2/3 of the BHB ≥1.5 mmol/L events were observed by Week 24. Conclusion: Treatment with SOTA was associated with small increases in BHB over time, which on average remained well below the clinically important level of 0.6 mmol/L. Although the DKA incidence was <4% overall on SOTA, the proportions of patients with ≥1 BHB measurement ≥0.6 mmol/L (∼45-47%) or ≥1.5 mmol/L (∼6-8%) suggest many BHB elevations were recognized and managed without progression to DKA. Disclosure A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. T. Danne: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Sanofi. S. Sawhney: None. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. M.J. Davies: Employee; Self; Lexicon Pharmaceuticals, Inc. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc.

1626-P: Differences in Patient-Reported Outcomes (PROs) by Age and Region in Adults with Type 1 Diabetes (T1D) in the SAGE Study

T1D is a chronic disease impacting patients’ lives and psychosocial health; we explored how this may vary by age and region. SAGE was a multinational, cross-sectional observational study using data from medical records and interviews of participants (N=3858) aged ≥26 years with T1D for ≥1 year. Results from PROs questionnaires (Hypoglycemia Fear Survey [HFS-II], Problem Areas in Diabetes [PAID], Insulin Treatment Satisfaction Questionnaire [ITSQ], Audit of Diabetes-Dependent Quality of Life [ADDQoL]) were analyzed by region (Asia [A], Eastern Europe [EE], Western Europe [WE], Latin America [LA], Middle East [ME]) and age group (26-<45; 45-<65; ≥65 years). HFS-II scores showed fear of hypoglycemia was lowest in A for all age groups (Table). HFS-II scores increased with age in EE and decreased with age in LA. PAID scores showed highest levels of emotional distress in ME for all age groups. ITSQ scores showed treatment satisfaction increased with age in WE, LA and ME, and was more stable in EE and A. ADDQoL total scores showed a small negative impact of T1D on quality of life, with the highest and lowest impact in EE and ME, respectively, across all ages. PROs scores indicated relatively low levels of diabetes-related impact and high treatment satisfaction. Age and regional differences may reflect variations in T1D control and management, as well as cultural and healthcare-system-related factors. Disclosure L. Berard: Consultant; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Becton, Dickinson and Company, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Montméd, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd. F. Ampudia Blasco: None. S. Brette: Other Relationship; Self; Sanofi. D. Bruttomesso: Consultant; Self; Abbott, Eli Lilly and Company, Movi, Novo Nordisk, Roche Diagnostics, Sanofi. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck & Co., Inc. H. Ikegami: None. D. Jurišic-Eržen: None. F. Lauand: Employee; Self; Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. V. Pilorget: Employee; Self; Sanofi. R. Balamurugan: None. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. A. Roborel de Climens: Employee; Self; Sanofi. Funding Sanofi

136-LB: Efficacy and Safety of Sotagliflozin (SOTA) in Patients with Type 2 Diabetes (T2D) and Moderate Renal Impairment

SOTA is a sodium-glucose linked cotransporter (SGLT)-1 in the GI tract and SGLT2 in the kidney. Compared to selective SGLT2 inhibitors, SOTA has the potential to retain glycemic-lowering efficacy in patients with renal insufficiency. In a 52-week, Phase 3 study, SOTA 200 and 400 mg QD, were evaluated in adults with T2D (HbA1C 7-11%) and Stage 3 CKD (eGFR ≥30-60 mL/min/1.73m2) to demonstrate statistical superiority vs. placebo (PBO) in reducing HbA1C at Week 26. Prespecified sequential testing of HbA1C reduction with SOTA 400 mg vs. PBO in the full CKD population was followed by Stage 3A and Stage 3B cohorts before testing SOTA 200 mg. ANCOVA models with retrieved dropouts and/or washout imputation methods were used for primary and prespecified secondary endpoints. In the full population (N=787), the least squares mean (LSM) difference between SOTA 400 mg and PBO for the change in HbA1C at Week 26 was −0.23% (p=0.002). In the CKD 3A (n=394) and CKD 3B cohorts (n=393), LSM differences for SOTA 400 mg vs. PBO were −0.31% (p=0.004) and −0.15% (p=0.158); respectively. SOTA 200 mg did not significantly reduce HbA1C in any cohort vs. PBO. In an exploratory analyses, PBO-corrected reductions in the urinary albumin-to-creatinine ratio were −38% (p<0.001) with SOTA 400 mg and −31% (p=0.001) with SOTA 200 mg. The expected “dip” in eGFR (3-4 mL/min/1.73 m2) with SOTA initiation was observed and trended back towards baseline. The rate of adverse events through 52 weeks was generally low. In the SOTA 400 mg, SOTA 200 mg, and PBO groups, genital mycotic infections (1.9%, 1.5%, and 0.8%), volume depletion (3.8%, 3.4%, and 1.5%), and diarrhea (8.5%, 6.7%, and 4.2%) were reported. Hypoglycemia ≤54 mg/dL was lower with SOTA 400 mg (5.4%) vs. PBO (10.8%). To conclude, statistically and clinically significant metabolic and renal effects of SOTA 400 mg were observed at 26 weeks in patients with T2D and Stage 3CKD. Long-term effects are being assessed in clinical outcomes trials. Disclosure D. Cherney: Research Support; Self; Boehringer Ingelheim-Lilly, Merck, Janssen, Sanofi, AstraZeneca and Novo-Nordisk. Other Relationship; Self; from Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Mitsubishi-Tanabe, Abbvie, Janssen, Bayer, Prometic, BMS and Novo-Nordisk. E. Ferrannini: Consultant; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Oramed Pharmaceuticals. Research Support; Self; AstraZeneca, Janssen Pharmaceuticals, Inc. G.E. Umpierrez: None. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. A.K. Carroll: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. S. Sawhney: None. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. W. Jiang: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc.

655-P: Improved Outcomes with Diabetes Devices Using Lower-Literacy Teaching Guides in a Center for Underserved Individuals with Type 1 Diabetes

Healthcare disparities exist between those in more or less affluent communities. This is particularly true for diabetes devices, where intensive training and follow-up is needed. Materials are generally written at an 11th grade reading level. Further, illustrations generally show low ethnic diversity. To reduce this educational gap, we created lower literacy, English and Spanish, multicultural guides for insulin pen and pump use. Focus groups provided input, nonbranded illustrations were created, and the text was edited by the “Clear Language Group.” Methods: The guides were implemented in our clinic for underserved, largely Hispanic, individuals in East Los Angeles. 47 adults with T1D were included. Subjects were given the low literacy guides and participated in guide driven individual and group education. Measures administered at baseline and 12 months were assessed for normality and independent sample t-tests. A 2-sided alpha of 0.05 was used. Results: Initial A1C was 9.2 +/- 1.97 (SD) with no change over the study course (12-month A1C = 9.3 +/- 1.92). However, patients showed an improved overall self-report of health (p = 0.012), improvement in diabetes knowledge (Michigan Diabetes Knowledge Test, p=.004), a reduction in symptoms of depression (PHQ8, p=.042), and diabetes distress (Diabetes Distress Scale, T1D Redeem, p = 0.0123). Though no change in rates of hypoglycemia, a reduction in fear of hypoglycemia (Hypoglycemia Fear Scale, Fear sub-scale, P=0.025) was significant. Additionally, there was a reduction in rates of DKA (0.0108). Time in range was minimal, based on blinded CGM, at baseline (22.4%) and did not change at 12 months (24.0%). CGM data was only available on 25 patients due to patient reluctance to wear the device. Conclusions: Appropriately targeted teaching guides can be used to improve a variety of outcomes in people with T1D, including rates of DKA. However, more work is needed to make a significant impact on glycemic control. Disclosure A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. M.A. Walker: None. V.F. Ruelas: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

1102-P: Impact of Treatment with Sotagliflozin on the Incidence of Severe Hypoglycemia in Patients with T1D

Objective: Severe hypoglycemia (SH) is an acute and life-threatening complication of T1D. Factors impacting the risk of SH include A1C, eGFR, insulin dose changes, and use of MDI versus CSII. An adjunctive treatment that simultaneously improves glycemic control and reduces SH across broad groups would be beneficial for patients (pts) with T1D. Methods: Data were pooled from two, 52-week, placebo (PBO)-controlled studies in adults with T1D in the overall population and in prespecified subgroups (Table). SH was defined using Level 3 hypoglycemia criteria and all events were independently adjudicated. Results reflect exposure-adjusted incidence rate per 100 patient-years. Results: Sotagliflozin (SOTA) 400 mg treatment significantly reduced the overall incidence of SH by 41% vs. placebo (relative risk [95% CI] 0.59 [0.35, 0.98]). A dose-responsive reduction was observed in the overall population, and maintained in subgroup analyses (Table), regardless of baseline A1C, eGFR, or percentage reduction in daily insulin dose. Patients using MDI versus CSII alone are generally at higher risk of SH. SOTA 400mg reduced the risk of SH by 69% (relative risk [95% CI] 0.31 [0.13, 0.68]) in MDI-treated pts but did not affect the relatively low rate in those using CSII. Conclusion: These data confirm that SOTA reduced the incidence of SH in pts with T1D, and indicates consistent dose-related risk reduction in almost all subgroups. Disclosure J. Pettus: Consultant; Self; Diasome Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk Inc., Sanofi. T. Danne: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. A.K. Carroll: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. S. Sawhney: None. W. Jiang: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. J.B. McGill: Advisory Panel; Self; Aegerion Pharmaceuticals, Bayer AG, Lilly Diabetes, Novo Nordisk A/S. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc. Research Support; Self; Medtronic, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Aegerion Pharmaceuticals, Dexcom, Inc., Janssen Pharmaceuticals, Inc.

135-LB: Efficacy and Safety of Sotagliflozin (SOTA) in Patients with Type 2 Diabetes (T2D) and Severe Renal Impairment

SOTA inhibits sodium-glucose cotransporter (SGLT) 1 in the GI tract and SGLT2 in the kidney. Compared to selective SGLT2 inhibitors, SOTA potentially retains glycemic lowering despite renal insufficiency. This is the first study of an SGLT-inhibitor to examine glycemic control in patients with T2D and Stage 4 CKD. In a 52-week, Phase 3 study, SOTA 200 and 400 mg QD were evaluated for superiority vs. placebo (PBO) in reducing HbA1C levels after 26 weeks. Adults had T2D, inadequate glycemic control (mean HbA1C, 8.0%), and severe CKD (mean eGFR, 23.6 mL/min/1.73 m2). Pre-specified efficacy endpoint data analyzed by an ANCOVA model combining retrieved dropout and washout imputation methods for missing data showed clinically meaningful HbA1C reduction with SOTA 400 mg vs. PBO of -0.30% (95% CI: −0.61, 0.02; p=0.062). In an analysis consistent with FDA recommendations applying an ANCOVA model using just the retrieved dropout imputation method, SOTA 400 mg (n=92) reduced HbA1C vs. PBO (n=92) by −0.33% (95% CI: 0.66, −0.001; p=0.049) at Week 26. SOTA 200 mg did not significantly reduce HbA1C vs. PBO. In key secondary endpoint analyses at Week 26, SOTA 400 mg reduced mean body weight vs. PBO by −1.53 kg (95% CI: −2.96, −0.09). In patients with baseline urinary albumin-to-creatinine-ratio (UACR) >30 mg/g, SOTA 400 mg reduced UACR vs. PBO by −27.04% (95% CI: −46.36, −0.75). At Week 12, SOTA 400 mg reduced SBP vs. PBO by −5.22 mm Hg (95% CI: −9.31, −1.13). The incidence of adverse events was 77.8% with SOTA vs. 74.2% with PBO. There were no treatment-group differences in mycotic infection (0% vs. 0%) or volume depletion (0% vs. 4.3%). Rates of level 1 and 2 hypoglycemia were lower with both doses of SOTA vs. PBO. At 26 weeks, SOTA 400 mg treatment resulted in meaningful reductions in HbA1C without unexpected safety concerns in adults with T2D and stage 4 CKD. The impact on renal and cardiovascular outcomes is being evaluated in a dedicated CVOT in patients with CKD. Disclosure D. Cherney: Research Support; Self; Boehringer Ingelheim-Lilly, Merck, Janssen, Sanofi, AstraZeneca and Novo-Nordisk. Other Relationship; Self; from Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Mitsubishi-Tanabe, Abbvie, Janssen, Bayer, Prometic, BMS and Novo-Nordisk. E. Ferrannini: Consultant; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Oramed Pharmaceuticals. Research Support; Self; AstraZeneca, Janssen Pharmaceuticals, Inc. G.E. Umpierrez: None. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. A.K. Carroll: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. W. Jiang: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. S. Sawhney: None.

37-OR: Racial and Socioeconomic Disparities in the Use of Newer Classes of Diabetes Medications

Among patients with type 2 diabetes (T2D), racial/ethnic minorities and those of lower socioeconomic status (SES) have a higher burden of coronary artery disease, chronic kidney disease, and hypoglycemia. Therefore, these groups may especially benefit from newer diabetes medication classes (GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors), but high cost may limit access. We conducted a secondary analysis of the Look AHEAD (Action for Health in Diabetes) randomized trial to assess the associations of race/ethnicity and SES with newer diabetes medication use. Look AHEAD compared an intensive lifestyle intervention to diabetes support and education among U.S. adults with obesity and T2D enrolled from 2001-2004. Medications, all prescribed outside of the study, were ascertained yearly. We used Cox proportional hazards models to estimate the association between self-reported race/ethnicity and SES factors and time to initiation of any newer diabetes medication through October 2019, adjusted for time-varying HbA1c, BMI, and number/type of diabetes medications; and baseline study arm, demographics, and comorbidities; fully-adjusted results are presented. Of 4,892 participants, 64%, 16%, 13%, and 8% were white, black, Hispanic, and other race/ethnicities, respectively. Over a median follow-up of 8.3 years, 44% initiated a newer diabetes medication. Black race was associated with significantly lower initiation of newer medications compared to whites (HR 0.81; 95% CI 0.80-0.94); there was no difference by other race/ethnic group. Yearly family income was inversely associated with the outcome: HR 0.69 (95% CI 0.55-0.87) comparing the lowest vs. the highest income group. Education, employment, and health insurance were not significantly associated with the outcome. These findings provide evidence of racial and SES disparities in use of newer diabetes medications, independent of glycemic control, that may impede access to these drugs for the individuals who need them most. Disclosure A. Elhussein: None. M. Bancks: None. W.C. Knowler: None. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. E.M. Vaughan: None. N.M. Maruthur: Other Relationship; Self; Johns Hopkins HealthCare Solutions. J. Clark: None. S.J. Pilla: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK057149)

Shear Bond Comparison between 4 Bioceramic Materials and Dual-cure Composite Resin

IntroductionBioceramic materials have shown biologic and physical properties favorable for regenerative treatment. A key to treatment success is an adequate restoration to prevent microleakage; however, research is limited regarding the bond strength between restorative and bioceramic materials used in regenerative procedures. This study compared the bond strength between 4 bioceramic materials and a dual-cure composite resin. MethodsEighty wells in Teflon (ePlastics, San Diego, CA) blocks were filled with bioceramic materials representing 4 groups: White ProRoot mineral trioxide aggregate (MTA) (Dentsply Tulsa Dental, Tulsa, OK), Biodentine (Septodont, Saint Maur des Fosses, France), EndoSequence Root Repair Material Fast Set Putty (Brasseler USA, Savannah, GA), and NeoMTA (Avalon Biomed Inc, Houston, TX). After allowing samples to set according to the manufacturers’ instructions, exposed surfaces of the bioceramic materials were prepared using ClearFil SE Bond (Kuraray America, Inc., New York, NY) followed by restoration with ClearFil DC Core Plus (Kuraray America, Inc.). To test shear bond strength, each block was secured in a universal testing machine, and the crosshead was advanced at 0.5 mm/min until fracture. Newton peak force was recorded and megapascals calculated followed by data comparison. ResultsThe mean shear bond strengths between ClearFil DC Core Plus and the bioceramic materials were as follows: White ProRoot MTA, 7.96 MPa; Biodentine, 9.18 MPa; EndoSequence Root Repair Material Fast Set Putty, 4.47 MPa; and NeoMTA, 5.72 MPa. White ProRoot MTA and Biodentine were statistically similar, with a higher stress bond strength than NeoMTA, which had a statistically greater bond strength than EndoSequence Root Repair Material. All these values were lower than typical bond strengths shown for dentin–composite resin bonding. ConclusionsThe choice of which bioceramic material to use in regenerative procedures should be based on factors other than the bond between that material and the overlying coronal resin restoration.

758-P: Medical Food (MF) with Butyrate Producing (BP)+Mucin Regulating (MR) Microbes Improves Glucose Control (GC) in T2D

Studies show that BP+MR are decreased inT2D; the impact of administering specific strains has not been reported. A 12-week, double blind, placebo-controlled study of 2 MFs prepared GMP using only GRAS constituents (MF-1: BP; MF-2: BP + MR) in T2D (drug naive + metformin ± SFU, n=76), showed improved GC. See Table for demographics and key results. The primary endpoint was change from baseline (∆) in total glucose AUC0-180 min during a Boost Plus™ (720 cal) MTT. At 12 weeks, MF-2 yielded significant ∆s in both total (T) and incremental (I) glucose AUC0-180 min, (p=0.05 and 0.007 respectively). MF-1 improved only I glucose AUC0-180 min (p=0.05). Neither MF-1 or MF-2 impacted fasting glucose, T or I insulin AUC0-180 min, weight, BMI, HOMA-IR, lipids, or c-reactive protein. No safety or tolerability concerns were observed. Pre and post fecal microbial analyses are pending. Post hoc analyses revealed 2 interesting results. 1) SFU subjects across both study groups showed minimal response while subjects not using SFUs had greater ∆s in both T glucose AUC0-180 min (-24.4%) and placebo-corrected ∆ A1c (-0.7%). 2) MF-2 showed significant reductions in ALT consistent with improved liver health. In conclusion, 1) Interventions directed at increasing BP+MR may be of benefit in T2D. 2) MF-2 appears to be a safe and effective non-pharmacologic intervention for T2D which merits further investigation. Disclosure O.G. Kolterman: Advisory Panel; Spouse/Partner; Intarcia Therapeutics, Inc. Advisory Panel; Self; Zafgen, Inc. Board Member; Self; American Diabetes Association, GlySens Incorporated, Viacyte, Inc. Consultant; Self; ADOCIA, Cirius Therapeutics Inc, DiaVacs Inc, JDRF, Nanoprecisionmedical, NuSirt Biopharma, Inc., Renova Therapeutics, Sensulin, LLC. Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Corcept Therapeutics, GI Therapeutics, Xeris Pharmaceuticals, Inc. Other Relationship; Spouse/Partner; American Diabetes Association. F. Perraudeau: Employee; Self; Whole Biome. M.S. Iyer: Employee; Self; Whole Biome Inc. J.S. Eid: Board Member; Self; Whole Biome Inc. J. Bullard: Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Whole Biome Inc. M.F. Schicklberger: Employee; Self; Whole Biome Inc. A. Cheng: None. N. Justice: Employee; Self; Whole Biome. P. McMurdie: Employee; Self; Whole Biome, Inc. B. Stoneburner: None. J. Gines: Employee; Self; Whole Biome Inc. S. Tyagi: None. C. Cutcliffe: Employee; Self; Whole Biome Inc.

135-OR: A Novel Thiazolidinedione (TZD) with Minimal PPAR-γ Activity Maximized for Mitochondrial Pyruvate Carrier (MPC) Modulation: Six-Month Analysis of Glycemia in a 12-Month Nonalcoholic Steatohepatitis (NASH) Study

The MPC facilitates entry of pyruvate into the Krebs cycle and in the setting of over nutrition, is critical to adverse manifestations including T2D and NASH. MSDC-0602K is a novel insulin sensitizer engineered to modulate pyruvate utilization with minimal ppar-γ activity. The EMMINENCE study is examining its effects on NASH and glycemia. U.S. sites (57) enrolled 402 patients with liver biopsy evidence of NASH and fibrosis; >50% of subjects with T2D (not taking insulin/pioglitazone) with entry HbA1c ≤ 9.5%. Randomization was 1:1:1:1 to daily oral doses of MSDC-0602K (62.5, 125, and 250mg) or placebo. Safety and glycemia were examined when 328 subjects reached 6 mo visit: 59% female, median age 57, 52% diabetic. (See Table) No meaningful changes in lipids, heart rate or BP were noted. The % of subjects reporting 1 or more adverse events was equal across all 4 cohorts. Importantly, the frequency of peripheral edema was 11% at baseline and unchanged across cohorts at 6 months. MSDC-0602K shows potent effects on glycemic control parameters and insulin sensitization with modest expected weight gain and no evidence of peripheral edema at 6 months, a key ppar-γ related side effect of first generation TZDs. This drug shows promise for glycemic control in NASH patients with T2D/insulin resistance. Disclosure K. Cusi: Consultant; Self; Allergan, AstraZeneca, Genentech, Inc., Novo Nordisk Inc., Poxel SA, ProSciento. Research Support; Self; Cirius Therapeutics, Echosens, Eli Lilly and Company, Inventiva Pharma, Janssen Research & Development, Novartis AG, Novo Nordisk Inc. O.G. Kolterman: Advisory Panel; Spouse/Partner; Intarcia Therapeutics, Inc. Advisory Panel; Self; Zafgen, Inc. Board Member; Self; American Diabetes Association, GlySens Incorporated, Viacyte, Inc. Consultant; Self; ADOCIA, Cirius Therapeutics Inc, DiaVacs Inc, JDRF, Nanoprecisionmedical, NuSirt Biopharma, Inc., Renova Therapeutics, Sensulin, LLC. Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Corcept Therapeutics, GI Therapeutics, Xeris Pharmaceuticals, Inc. Other Relationship; Spouse/Partner; American Diabetes Association. S.A. Harrison: Advisory Panel; Self; Gilead Sciences, Inc. H.C. Dittrich: Employee; Self; Cirius Therapeutics.

2046-P: NS-0200 (Leucine-Metformin-Sildenafil) Reduces Weight in Obese Subjects: A 24-Week Randomized Trial

We previously showed leucine to activate the SIrt1/AMPK/NO pathway and to synergize with other activators of this pathway, and developed NS-0200 (leucine-metformin-sildenafil combination) to treat diseases of energy dysregulation. During a previous trial of NS-0200 of nonalcoholic fatty liver disease we noted significant weight loss induced by NS-0200. Accordingly, we have conducted a 24-week placebo-controlled double-blind trial in 258 weight-stable obese subjects to evaluate the effects of leucine (1.1 g) + sildenafil (1 or 4 mg) with or without metformin (500 mg) administered b.i.d. on weight loss in the absence of lifestyle modification; data presented are for the 202 per-protocol completers. Leu/Met/Sil 1.0 or 4.0 mg and Leu/Sil 4.0 mg produced significant weight loss, while LeuSil 1.0 mg did not. Leu/Met/Sil 1.0 mg exerted the greatest effect (2% placebo-adjusted weight loss, p<0.01), with a greater effect in subjects with BMI<40 (2.9% weight loss, 23% of subjects achieved ≥ 5% weight loss). Markedly greater effects were found in African-American (AA) subjects (6% weight loss, p<0.01) and those with BMI 35-39.9 (4.2% weight loss, p<0.001). These sub-group differences were explained, in part, by differences in baseline insulin and insulin resistance. 71% of AA had insulin ≥ 8 mU/L and HOMAIR>2, vs. 42% in Caucasians, and Leu/Met/Sil 1.0 resulted in a 61% decrease in both insulin and HOMAIR(p<0.009) in AA. Similarly, treated subjects with BMI 35-39.9 had ∼two-fold elevations in insulin and HOMAIR vs. those with BMI<35, and 77% had insulin ≥ 8 mU/L and HOMAIR>2 (p=0.017); those with elevated insulin at baseline lost ∼twice as much weight as those with lower insulin (-3.8 vs. -1.8%), and 30% of this subgroup achieved 5% weight loss vs. 6% of placebo. These data indicate NS-0200 results in significant 6-month weight loss, especially in insulin-resistant subjects, and suggest therapeutic utility for obese insulin-resistant individuals. Disclosure M.B. Zemel: Board Member; Self; NuSirt Biopharma, Inc. Employee; Self; NuSirt Biopharma, Inc. Stock/Shareholder; Self; NuSirt Biopharma, Inc. O.G. Kolterman: Advisory Panel; Spouse/Partner; Intarcia Therapeutics, Inc. Advisory Panel; Self; Zafgen, Inc. Board Member; Self; American Diabetes Association, GlySens Incorporated, Viacyte, Inc. Consultant; Self; ADOCIA, Cirius Therapeutics Inc, DiaVacs Inc, JDRF, Nanoprecisionmedical, NuSirt Biopharma, Inc., Renova Therapeutics, Sensulin, LLC. Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Corcept Therapeutics, GI Therapeutics, Xeris Pharmaceuticals, Inc. Other Relationship; Spouse/Partner; American Diabetes Association. O. Flores: None. G. Fleming: Advisory Panel; Self; ADOCIA, Biocon. Consultant; Self; Enanta Pharmaceuticals, Inc., InsuLine Medical Ltd., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Merck KGaA, Oramed Pharmaceuticals, Orgenesis Ltd., Sanofi. Employee; Self; Tolerion, Inc. F.L. Greenway: Advisory Panel; Self; BAROnova, Gelesis, Jenny Craig - Curves, Novartis Pharmaceuticals Corporation, NuSirt Biopharma, Inc., Zafgen, Inc. Consultant; Self; Academic Technology Ventures, Basic Research, General Nutrition Corporation, Melior Discoveries. Research Support; Self; Microbiome Therapeutics. Stock/Shareholder; Self; Plensat, Slim Health Nutrition. Other Relationship; Self; Neuroquest. Funding NuSirt Biopharma, Inc.

Evaluation of changes in ion release and biological properties of NeoMTA-Plus and Endocem-MTA exposed to an acidic environment.

To analyse invitro changes in ion release and biological properties of Endocem-MTA (Maruchi, Wonju, Korea) and NeoMTA-Plus (Avalon Biomed Inc, Bradenton, FL, USA) exposed to acidic or neutral environment on human dental periodontal ligament stem cells (hPDLSCs). Cell viability and wound healing assays were performed using eluates of each material. Cell death and changes in phenotype induced by the set endodontic sealer eluates were evaluated through flow cytometry. To evaluate cell attachment to the different materials, hPDLSCs were directly seeded onto the material surfaces and analysed by scanning electron microscopy. The chemical composition of the materials was determined by energy-dispersive X-ray (EDX), and ion release was evaluated by inductively coupled plasma-mass spectrometry. Statistical analysis was performed with analysis of variance and a Bonferroni or Tukey post-test (α<0.05). The MTT assay revealed non-cytotoxic effects of NeoMTA-Plus and Endocem-MTA at pH 5.2 and 7.4. However, there were minor differences compared with the control, especially at pH 5.2, where both materials were associated with significantly greater cell viability (P<0.05). In both environments, the materials stimulated hPDLSCs to migrate. hPDLSCs were attached to the bioactive cements, with multiple prolongations proliferated on the surface of the samples. Moreover, there were no changes to cell phenotype or apoptosis/necrosis rates, indicating that the acidic environment did not induce cell death. Prismatic crystalline structures were seen on the surface of the cements exposed to butyric acid and EDX analysis identified a marked peak of Ca2+ from NeoMTA-Plus and Endocem-MTA in acidic and physiological environments. An acidic environment favoured the release of Ca2+ ions from both bioactive cements, and the cytotoxicity of these bioactive cements was low in both environments studied.

Histology of NeoMTA Plus and Quick-Set2 in Contact with Pulp and Periradicular Tissues in a Canine Model

IntroductionNeoMTA Plus (Avalon Biomed Inc, Bradenton, FL) is a tricalcium silicate material similar to the first mineral trioxide aggregate product, ProRoot MTA (Dentsply Sirona, York, PA), but with improvements such as decreased setting time, increased ion release, increased water sorption, and nonstaining radiopacifiers. Quick-Set2 (Avalon Biomed Inc) is a newly formulated calcium aluminosilicate material that has a faster setting time and increased acid resistance and is nonstaining. The purpose of this study was to compare the healing of pulpal and periapical tissues in dogs after exposure to NeoMTA Plus and Quick-Set2 after pulpotomy and root-end surgery procedures. MethodsSeventy-two teeth (36 for each procedure) in 6 beagle dogs received pulpotomy or root-end surgery using either NeoMTA Plus or Quick-Set2. The dogs were sacrificed at 90 days, and the teeth and surrounding tissues were prepared for histologic evaluation. Sixty teeth were evaluated and scored histologically (29 with pulpotomies and 31 with root-end resections). Specimens were scored for inflammation, quality and thickness of dentin bridging, pulp tissue response, cementum and periodontal ligament formation, and apical bone healing. ResultsBoth materials displayed favorable healing at 90 days. The only significant difference was the quality of dentin bridge formation in pulpotomies using NeoMTA Plus compared with Quick-Set2. ConclusionsQuick-Set2 and NeoMTA Plus had similar effects on inflammation, pulp response, periodontal ligament and cementum formation, and apical tissue healing in dogs. NeoMTA Plus had superior dentin bridge quality compared with Quick-Set2.